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Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

Exploring Bleximenib with standard treatments for Acute Myeloid Leukemia.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

Acute Myeloid Leukemia (AML) is a type of cancer affecting blood and bone marrow. This study looks at a new medicine, *Bleximenib*, used with standard chemotherapy for adults with AML who have certain genetic changes (mutations in *NPM1* or *KMT2A* genes). Bleximenib works by stopping certain proteins from helping leukemia cells grow, causing them to die. The study aims to see if adding Bleximenib to regular treatment improves patient outcomes.

This is a **Phase 3 clinical trial**, meaning it tests how well the treatment works and its safety on a larger group. Participants will be randomly assigned to receive either Bleximenib or a placebo (a pill with no medicine, like a sugar pill) along with standard chemotherapy. Neither doctors nor participants will know who receives Bleximenib or the placebo (double-blind).

  • The study includes 875 patients aged 18 or older with newly diagnosed AML, eligible for intensive chemotherapy.
  • It involves an observational follow-up for 4 years after treatment to compare results.
  • Patients with prior AML treatment, certain heart issues, or organ transplants are not eligible.
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Study details
    Acute Myeloid Leukemia

NCT07223814

Stichting Hemato-Oncologie voor Volwassenen Nederland

11 October 2026

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